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Vascular and Interventional Radiology |
1 From the Department of Radiology, Division of Cardiovascular-Interventional Radiology, Stanford University Hospital, Ste H-3651, 300 Pasteur Dr, Stanford, CA 94305-1056. Received November 19, 1998; revision requested December 22; revision received April 1, 1999; accepted May 25. Address reprint requests to M.K.R. (e-mail: mrazavi@stanford.edu).
| Abstract |
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MATERIALS AND METHODS: Seventeen consecutive patients (12 male, five female patients; mean age, 40.6 years; age range, 1577 years) with chronic IVC occlusions were treated during a 6-year period. The mean duration of symptoms was 32 months. Underlying active malignancy was the cause of occlusion in four patients. Five patients with superimposed acute thrombus underwent catheter-directed thrombolysis prior to IVC recanalization. Clinical patency was defined as absence or improvement of symptoms. Clinical follow-up was supplemented with ultrasonography, vena cavography, or both in 10 patients.
RESULTS: Technical success was achieved in 15 (88%) patients. Additional thrombolytic therapy and stent placement was needed in two patients to maintain patency at 4 and 6 months after the procedure. Twelve patients had IVCs that remained patent after a mean follow-up of 19 months for a primary patency rate of 80%. The primary assisted patency rate was 87% (13 of 15). There were four deaths owing to underlying disease 621 months after the procedures. There were no procedure-related complications.
CONCLUSION: Endoluminal recanalization and stent placement in chronically occluded IVCs has a good intermediate-term outcome and should be considered in patients who have symptoms and who often do not have adequate alternative therapy.
Index terms: Venae cavae, grafts and prostheses, 569.126, 949.1268 Venae cavae, interventional procedures, 569.126, 949.1268 Venae cavae, stenosis or obstruction, 569.30, 569.40, 949.30, 949.40, 949.72 Venae cavae, thrombosis, 569.1265, 949.1265, 949.751
| Introduction |
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The purpose of this study was to present our experience with endoluminal recanalization of and stent placement in chronically occluded IVCs in 17 patients with symptoms; the objective was to evaluate the feasibility of endoluminal therapy in these patients. To our knowledge, this is the first such report in the literature.
| MATERIALS AND METHODS |
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For purposes of this study, chronic occlusion was defined as symptoms, objective imaging evidence, or both of occlusion longer than 3 months in duration. Patients had chronic symptoms of IVC occlusion, including leg swelling, pain and cramps, weakness, lower extremity pigmentation, and decreased exercise tolerance. The mean duration of symptoms was 32 months (range, 1276 months). Patient characteristics and the causes of IVC occlusions are listed in Table 1. Although patient 14 had symptoms for only 1 month, she was included in this study because she had ultrasonographic (US) evidence of iliocaval occlusion 5 months prior to presentation.
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Patients 1, 4, 6, 14, and 15 were thought to have a component of superimposed acute thrombosis and were first treated with overnight infusion of urokinase (Abbokinase; Abbott Laboratories) at a mean dosage of 130,000 IU/h. The presence of acute clot was determined on the basis of the venographic appearance of thrombosed vein (intraluminal filling defects in expanded vein) and the ease of clot penetration with use of a soft guide wire (guide-wire test). This was limited to either the iliac vein or veins or a combination of the iliac and collateral veins in all five patients.
Recanalization of the chronically occluded venous segments was attempted by using a Berenstein Glidecath catheter and Glidewire (Boston Scientific, Natick, Mass). Two patients required sharp instrument probing with the back end of a wire to connect the short segments (<3 cm) between the superiorly and inferiorly created channels. The wire introduced through the jugular access was then snared from the groin by using a vascular snare (Amplatz; Microvena, St Paul, Minn) to allow femoral access to the entire length of the occluded IVC. The occluded segments were then predilated by using a balloon of smaller caliber than the IVC to allow stent placement. Balloon expandable Palmaz stents (Cordis Endovascular, Warren, NJ) were used in five patients, self-expanding Wallstents (Boston Scientific) were used in eight, and a combination of both stents were used in one (Table 2).
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The end point of the procedures in these patients was determined by means of venographic criteria of rapid flow through the created lumina and disappearance of collateral venous circulation.
All patients underwent anticoagulation therapy with heparin sodium (Heparin; Wyeth Laboratories, Philadelphia, Pa) during the procedure and received warfarin sodium (Coumadin; Dupont, Wilmington, Del) to achieve an international normalized ratio, or INR, of 23 for at least 46 months. Longer anticoagulation therapy was instituted for patients with uncorrectable underlying hypercoagulable states.
Follow-up for these venous interventions consisted of office visits and venous US at 3 months and at 6 and 12 months (± 2 months) after the procedure, and as patient symptoms required thereafter. This follow-up regimen was available in 10 patients. Longer follow-up data for these patients who were also seen in other clinics for various medical conditions were obtained from their medical records. Clinical patency was assessed in five others who lived in distant geographic locations by means of phone conversations with the patients, their private physicians, or both. The remaining two who were not treated successfully were not seen at follow-up.
Follow-up digital subtraction vena cavography was performed in patients 1, 4, 12, and 13 because they were clinically suspected of having restenosis or reocclusion. Technical success was defined as successful passage of the guide wire through the occluded vein, and clinical success was defined as complete resolution of or substantial improvement in patient symptoms.
| RESULTS |
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Patient 9 was one of the two patients with a failed procedure because he had no suitable inferior access owing to long-standing iliofemoral deep venous thrombosis. Efforts to recanalize the entire infrahepatic IVC and iliofemoral venous segments through a jugular access in this patient were unsuccessful. In the other patient, attempts to traverse the occluded IVC from both femoral and jugular accesses failed.
Stents were placed in 14 of the 15 patients who underwent successful recanalization. Fifty-five stents were used in these patients26 Palmaz stents and 29 Wallstentsand all were balloon dilated after placement. Adjuvant therapy was needed to maintain patency at 6 and 4 months after the procedure in patients 1 and 4, respectively.
Patient 1, who had chronic renal failure, required thrombolysis for a symptomatic left lower extremity iliofemoral deep venous thrombosis, presumably related to her hypercoagulable state. She also had developed right common iliac venous stenosis secondary to placement of a dialysis access graft in her right groin. Stents subsequently were placed in both common iliac veins in this patient.
Patient 4 required another intervention on two different occasionswith iliac venous thrombolysis and with extension of the stents into the iliac and femoral veins. This patient, who also had Behcet disease with recurrent symptoms 6 months after the last intervention, was discovered to have rethrombosis of his iliocaval venous segments. His symptoms gradually improved with anticoagulation therapy and treatment of the underlying Behçet disease.
The only other IVC thrombosis in this series was in patient 6, who had been treated with thrombolysis and angioplasty alone. This patient had no relief of symptoms after the procedure, and follow-up US revealed evidence of IVC reocclusion. This likely occurred owing to venous recoil. All other patients treated successfully had complete or substantial relief of symptoms within 48 hours. Patients 12 and 13 had recurrence of mild lower extremity edema with no evidence of hemodynamically significant in-stent restenosis or rethrombosis at follow-up venography.
Of the 15 patients whose IVCs were successfully recanalized, 12 had IVCs that remained patent without any further interventions for a primary patency rate of 80% after a mean follow-up of 19 months (range, 260 months). The primary assisted patency rate among the patients in our study was 87% (13 of 15). There were four deaths (patients 2, 5, 8, and 11) in the follow-up period owing to underlying disease. The deaths occurred 621 months after the procedures (mean, 10.5 months). No follow-up data were obtained in patients 7 and 9, whose procedures were the technical failures in this series.
Four patients had transient pain that resolved spontaneously without any specific treatment during balloon angioplasty, stent placement, or both in the IVC. As mentioned earlier, patient 6 had acute reocclusion of the IVC after recanalization. No other complications were encountered in this study.
| DISCUSSION |
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IVC occlusion due to benign causes poses a different clinical challenge, as the maintenance of IVC patency and relief of symptoms should be extended over many years. In our study, there were four patients with active malignancy, and the remaining patients were either in remission or had benign disease. In general, therefore, the procedures were not intended as short-term palliative therapy but rather as a long-term solution for patients with normal life expectancies. In these cases, the surgical approach often is limited by the availability and suboptimal results of appropriate venous conduits and prosthetic grafts (6,7,18,19).
Gloviczki et al (6) in their report on the effectiveness of venous grafting in 28 patients with superior vena caval or iliocaval obstruction concluded that whereas a spiral saphenous venous graft appears to be a good conduit for superior vena caval bypass, its application is limited in IVC obstruction. In their series, 43% of the patients had to undergo additional surgeries, 29% of which were to maintain patency at a median follow-up of 2 years. Of the 11 patients with abdominal or pelvic bypass grafts made of expanded polytetrafluoroethylene, only seven (64%) patients had grafts that were patent after a mean follow-up of 9 months.
Results of angioplasty alone have also been disappointing (20,21). This is particularly true in the setting of chronic venous occlusions due to venous recoil, low flow state, and thrombogenicity of the lumen. The only acute reocclusion of IVC in our series occurred in the patient who was treated with angioplasty alone at the request of the patient and the referring physician.
Stents potentially can improve the outcome of endoluminal interventions in large veins, mainly by preventing recoil. The large venous conduit presumably then would have sufficient flow to maintain patency. This, however, remains largely a theoretic advantage, since caval patency after stent placement for benign disease is not well established in the literature. The issue is better studied in the superior vena cava, where response rates of 68%-100% have been reported (2225). Most reports in the literature are on patients with malignant superior vena cava syndrome. In the series by Kee et al (22), 16 of the 59 patients treated had benign disease. The primary and secondary clinical patency rates in 13 of these patients who were available for follow-up were 77% and 85%, respectively, after a mean follow-up of 17 months.
There are relatively few published reports on stent placement in the IVC, and the long-term outcome is not well known. Most of these articles are about patients with Budd-Chiari syndrome rather than IVC syndrome, and the chronicity of the process is not well established or reported (2630).
In the series by Nazarian et al (9), two of the three patients who were treated with IVC stents had occlusions of uncertain duration, and one remained patent at 1 year. Park et al (29) reported stent placement in seven patients with benign segmental obstruction of the hepatic IVC and achieved a primary patency rate of 71% (five of seven) after a mean follow-up of 12 months. Nine of the 10 patients with Budd-Chiari syndrome who were treated by Kaul et al (30) remained symptom free 113 months after IVC stent placement. Good clinical outcome of hepatic IVC stent placement was also seen in this series of patients with chronic occlusion of the infrarenal IVC with a primary assisted patency rate of 87% after a mean follow-up of 19 months.
Although the percutaneous recanalization of chronically occluded venous channels can be a difficult and time-consuming task, our attempts were successful in 15 of the 17 patients. Stents remained patent in all but one patient, as described, despite the fact that these slow flow channels were created through organized clot and fibrotic luminaall conditions that predispose the patient to thrombosis. No arteriovenous fistula to maintain patency was created in this study. In our experience, arteriovenous fistulas have not been necessary in cases in which the treated venous segment has good inflow and outflow.
The anticoagulation regimen used in the patients with no underlying hypercoagulability presumably would allow for reendothelialization of the lumina, which renders them less thrombogenic. Although delayed reendothelialization has been shown to promote intimal proliferation (3133), the beneficial effects of this short-term anticoagulation protocol on the rate of reendothelialization or rethrombosis remain unproved.
The symptoms of most patients with occlusion of the infrarenal IVC improve beyond the acute phase owing to establishment of collateral pathways. In some, the venous outflow obstruction causes venous hypertension and valvular incompetence over time (5), which leads to recurrence of symptoms. In others, acute thrombosis of iliofemoral veins or collateral circulation may worsen the existing symptoms and cause patients to seek medical attention. In many patients, therefore, there is not a good correlation between the onset of symptoms and the actual thrombosis of the IVC. This was also true in this series. With the exception of patients 12 and possibly 17, the actual time of IVC thrombosis was unknown among these patients.
No complications were encountered in this small series of patients, which confirms the safety of this approach. Specifically, there were no clinically detectable pulmonary emboli, infection, bleeding, hematoma, or stent migration or misplacement. Four patients had pain that resolved spontaneously without any sequelae during balloon dilation and stent placement in the IVC.
The intermediate-term results of the endovascular stent placement in the chronically occluded IVCs reported in this limited number of patients are encouraging. The safety and efficacy of endovascular stent placement offers patients with symptoms of chronically occluded IVC an alternative to both the medical and surgical therapies. Further studies of the long-term outcome in these patients and the influence of factors such as the amount of flow through the stents, the status of competitive flow through the collateral vessels, and the degree of venous reflux on the patency of the created lumina are warranted.
| Footnotes |
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Author contributions: Guarantors of integrity of entire study, M.K.R., M.D.D.; study concepts and design, M.K.R., C.P.S., M.D.D.; definition of intellectual content, M.K.R., C.P.S., M.D.D.; literature research, M.K.R., E.C.H.; clinical studies, M.K.R., D.Y.S., S.T.K., C.P.S., M.D.D.; data acquisition and analysis, M.K.R., E.C.H., C.P.S.; manuscript preparation, M.K.R., E.C.H.; manuscript editing and review, M.K.R., C.P.S., M.D.D.
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This article has been cited by other articles:
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H McGee, D Maudgil, A Tookman, A Kurowska, and A F Watkinson A case series of inferior vena cava stenting for lower limb oedema in palliative care Palliative Medicine, September 1, 2004; 18(6): 573 - 576. [Abstract] [PDF] |
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